VergeRx for Smokers Not Ready to Quit

NCT07693660 | Not Yet Recruiting DMC

• 1 other identifier: HSR303823
• Study Type: interventional
• Target: 592
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses a factorial optimization experiment to identify which treatment components help adults who smoke and are not ready to quit in the next 30 days (smokers not ready to quit, or SNRTQ) achieve smoking cessation. Participants are recruited through Federally Qualified Health Centers (FQHCs) in Virginia and West Virginia. All participants receive at least 8 weeks of nicotine replacement therapy (NRT) patch. Using a 2×2×2×2 factorial design, the study independently tests four components: a pharmacist-delivered behavioral program (VergeRx), a text-message support program (SmokefreeTXT), the addition of an NRT lozenge to the patch, and an extended 16-week course of the NRT patch versus the standard 8 weeks. The goal is to estimate the effect of each component on biochemically confirmed smoking abstinence so that an optimized treatment package can be assembled. The primary outcome is abstinence at 26 weeks; a secondary outcome is abstinence at 52 weeks.

Conditions

Tobacco Use Cessation

Keywords

federally qualified health center; rural; urban; appalachia; smoking cessation; readiness to quit; smokers not ready to quit; pharmacists; low income; medicaid

Outcome Measures

Primary Outcomes (1)

• Biochemically confirmed 7-day point prevalence cigarette abstinence at 26 weeks

  Point prevalence abstinence, defined as no cigarette smoking (not even a puff) within the past 7 days, biochemically confirmed using a CoVita Smokerlyzer carbon monoxide (CO) monitor at the FQHC. Participants unable to travel who report no combustible tobacco use are mailed a cotinine test completed via Zoom. Participants who do not provide outcome data are classified as smoking.

  26 weeks after enrollment

Secondary Outcomes (1)

• Biochemically confirmed 7-day point prevalence cigarette abstinence at 52 weeks

  52 weeks after enrollment

Other Outcomes (8)

• Motivation to quit

  Baseline through 52 weeks

• Cigarettes smoked per day

  Baseline through 52 weeks

• Adherence to NRT

  Weeks 1 through 52

Study Arms (16)

VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge

EXPERIMENTAL

VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge

Behavioral: VergeRx; Behavioral: SmokefreeTXT; Drug: NRT Lozenge (Combination); Drug: Extended NRT Patch (16 weeks)

VergeRx + SmokefreeTXT + 16-wk Patch

EXPERIMENTAL

VergeRx; SmokefreeTXT; Extended NRT Patch (16 wk)

Behavioral: VergeRx; Behavioral: SmokefreeTXT; Drug: Extended NRT Patch (16 weeks)

VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge

EXPERIMENTAL

VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge

Behavioral: VergeRx; Behavioral: SmokefreeTXT; Drug: NRT Lozenge (Combination); Drug: Standard NRT Patch (8 weeks)

VergeRx + SmokefreeTXT + 8-wk Patch

EXPERIMENTAL

VergeRx; SmokefreeTXT; Standard NRT Patch (8 wk)

Behavioral: VergeRx; Behavioral: SmokefreeTXT; Drug: Standard NRT Patch (8 weeks)

VergeRx + 16-wk Patch + Lozenge

EXPERIMENTAL

VergeRx; Extended NRT Patch (16 wk); NRT Lozenge

Behavioral: VergeRx; Drug: NRT Lozenge (Combination); Drug: Extended NRT Patch (16 weeks)

VergeRx + 16-wk Patch

EXPERIMENTAL

VergeRx + 16-wk Patch

Behavioral: VergeRx; Drug: Extended NRT Patch (16 weeks)

VergeRx + 8-wk Patch + Lozenge

EXPERIMENTAL

VergeRx; Standard NRT Patch (8 wk); NRT Lozenge

Behavioral: VergeRx; Drug: NRT Lozenge (Combination); Drug: Standard NRT Patch (8 weeks)

VergeRx + 8-wk Patch

EXPERIMENTAL

VergeRx; Standard NRT Patch (8 wk)

Behavioral: VergeRx; Drug: Standard NRT Patch (8 weeks)

SmokefreeTXT + 16-wk Patch + Lozenge

EXPERIMENTAL

SmokefreeTXT; Extended NRT Patch (16 wk); NRT Lozenge

Behavioral: SmokefreeTXT; Drug: NRT Lozenge (Combination); Drug: Extended NRT Patch (16 weeks)

SmokefreeTXT + 16-wk Patch

EXPERIMENTAL

SmokefreeTXT; Extended NRT Patch (16 wk)

Behavioral: SmokefreeTXT; Drug: Extended NRT Patch (16 weeks)

SmokefreeTXT + 8-wk Patch + Lozenge

EXPERIMENTAL

SmokefreeTXT; Standard NRT Patch (8 wk); NRT Lozenge

Behavioral: SmokefreeTXT; Drug: NRT Lozenge (Combination); Drug: Standard NRT Patch (8 weeks)

SmokefreeTXT + 8-wk Patch

EXPERIMENTAL

SmokefreeTXT; Standard NRT Patch (8 wk)

Behavioral: SmokefreeTXT; Drug: Standard NRT Patch (8 weeks)

16-wk Patch + Lozenge

EXPERIMENTAL

Extended NRT Patch (16 wk); NRT Lozenge

Drug: Extended NRT Patch (16 weeks)

16-wk Patch

EXPERIMENTAL

Extended NRT Patch (16 wk)

Drug: Extended NRT Patch (16 weeks)

8-wk Patch + Lozenge

EXPERIMENTAL

Standard NRT Patch (8 wk); NRT Lozenge

Drug: Standard NRT Patch (8 weeks)

8-wk Patch (reference)

EXPERIMENTAL

Standard NRT Patch (8 wk)

Drug: Standard NRT Patch (8 weeks)

Interventions

VergeRx BEHAVIORAL

Up to three pre-quit modules delivered by a local pharmacist/technician to promote NRT adherence; upon reported readiness to quit (assessed at weekly REDCap check-ins), participants advance to six treatment sessions over four weeks. Component ends if readiness is not reported after four weekly check-ins.

VergeRx + 16-wk Patch; VergeRx + 16-wk Patch + Lozenge; VergeRx + 8-wk Patch; VergeRx + 8-wk Patch + Lozenge; VergeRx + SmokefreeTXT + 16-wk Patch; VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge; VergeRx + SmokefreeTXT + 8-wk Patch; VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge

SmokefreeTXT BEHAVIORAL

Up to three 7-day pre-quit "Daily Challenges" text modules; upon reported readiness to quit, the SmokefreeTXT program delivers 3-5 messages/day for seven weeks. Component ends if readiness is not reported after four weekly check-ins.

SmokefreeTXT + 16-wk Patch; SmokefreeTXT + 16-wk Patch + Lozenge; SmokefreeTXT + 8-wk Patch; SmokefreeTXT + 8-wk Patch + Lozenge; VergeRx + SmokefreeTXT + 16-wk Patch; VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge; VergeRx + SmokefreeTXT + 8-wk Patch; VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge

NRT Lozenge (Combination) DRUG

Nicotine lozenge provided in addition to the NRT patch (combination NRT vs. patch monotherapy).

SmokefreeTXT + 16-wk Patch + Lozenge; SmokefreeTXT + 8-wk Patch + Lozenge; VergeRx + 16-wk Patch + Lozenge; VergeRx + 8-wk Patch + Lozenge; VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge; VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge

Extended NRT Patch (16 weeks) DRUG

Nicotine patch provided for 16 weeks.

16-wk Patch; 16-wk Patch + Lozenge; SmokefreeTXT + 16-wk Patch; SmokefreeTXT + 16-wk Patch + Lozenge; VergeRx + 16-wk Patch; VergeRx + 16-wk Patch + Lozenge; VergeRx + SmokefreeTXT + 16-wk Patch; VergeRx + SmokefreeTXT + 16-wk Patch + Lozenge

Standard NRT Patch (8 weeks) DRUG

Nicotine patch provided for 8 weeks (all participants receive at least 8 weeks of patch beginning Week 1).

8-wk Patch (reference); 8-wk Patch + Lozenge; SmokefreeTXT + 8-wk Patch; SmokefreeTXT + 8-wk Patch + Lozenge; VergeRx + 8-wk Patch; VergeRx + 8-wk Patch + Lozenge; VergeRx + SmokefreeTXT + 8-wk Patch; VergeRx + SmokefreeTXT + 8-wk Patch + Lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Not ready to quit smoking in the next 30 days
• Age ≥ 18 years
• Able to read, speak, and understand English
• Report smoking ≥ 5 cigarettes per day for the past 6 months
• Own a cell phone
• Willing and able to use nicotine replacement therapy (NRT) in the form of patch and lozenge

You may not qualify if:

• Currently pregnant, or planning to become pregnant in the next 6 months

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Melissa Little, PhD, MPH

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa A Little

CONTACT

4349241935; mal7uj@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a 2×2×2×2 fully-crossed factorial optimization experiment conducted within the optimization phase of the Multiphase Optimization Strategy (MOST) framework. Four treatment components are independently randomized: (1) VergeRx (yes/no), (2) SmokefreeTXT (yes/no), (3) combination NRT lozenge added to the NRT patch (vs. patch alone), and (4) 16 weeks of NRT patch (vs. the standard 8 weeks). The crossing of these four two-level factors yields 16 experimental conditions. This is not a 16-arm comparative trial; individual conditions are not compared to one another. Instead, the analysis estimates the main effect of each component by pooling across all conditions-comparing the \~296 participants who receive a component against the \~296 who do not. All participants receive at least 8 weeks of NRT patch beginning in Week 1.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): November 1, 2032
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)